Can Resistance Enhance Selection of Treatment? (CREST)

This study has been completed.

Sponsors and Collaborators:	The National Centre in HIV Epidemiology and Clinical Research Abbott Boehringer Ingelheim Pharmaceuticals GlaxoSmithKline Bristol-Myers Squibb Merck Hoffmann-La Roche Virco Diagnostic Technology Perkin Elmer Biosystems
Information provided by:	The National Centre in HIV Epidemiology and Clinical Research
ClinicalTrials.gov Identifier:	NCT00262717

Purpose

To compare two commercially available platforms for assessment of HIV drug resistance to determine which provides superior virological results.

We hypothesise that one test will be significantly superior to the other.

Condition	Intervention	Phase
HIV Infection	Device: HIV drug resistance tests based upon genotype testing	Phase IV

MedlinePlus related topics: AIDS

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Diagnostic, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:	A Randomised Comparator Study to Assess the Relative Efficacy of Genotypic Versus Virtual Phenotypic Resistance Tests in Treatment Experienced Patients With HIV Infection for Whom a Change in Therapy is Indicated

Further study details as provided by The National Centre in HIV Epidemiology and Clinical Research:

Primary Outcome Measures:

The comparison between randomly assigned study arms in the mean area under the curve plasma HIV RNA at 48 weeks.

Secondary Outcome Measures:

Proportion of patients with undetectable plasma HIV RNA, Changes in CD4+ cell count, use of resistance test result in selecting new ART regimen

Estimated Enrollment:	300
Study Start Date:	March 2001
Estimated Study Completion Date:	August 2002

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

HIV infected patients taking combination antiretroviral therapy, with plasma HIV RNA> 2000copies/mL, who were willing to change ARVs and who provided informed consent.

Exclusion Criteria:

Patients who were ARV naïve, who were experiencing an acute illness or judged to be unable to comply with the protocol requirements.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00262717

Locations

Australia, Australian Capital Territory
Interchange General Practice
Canberra, Australian Capital Territory, Australia
Australia, New South Wales
AIDS Research Initiative
Sydney, New South Wales, Australia, 2010
Albion Street Centre
Sydney, New South Wales, Australia, 2010
Holdsworth House General Practice
Sydney, New South Wales, Australia, 2010
Sydney Sexual Health Clinic
Sydney, New South Wales, Australia, 2000
Royal Prince Alfred Hospital
Camperdown, New South Wales, Australia, 2050
St. Vincent's Hospital
Sydney, New South Wales, Australia, 2010
Taylor Square Private Clinic
Sydney, New South Wales, Australia, 2010
Prince of Wales Hospital
Sydney, New South Wales, Australia, 2031
Livingston Road Sexual Health
Sydney, New South Wales, Australia
Australia, Queensland
Cairns Base Hospital
Cairns, Queensland, Australia, 4870
Gold Coast Sexual Health Clinic
Miami, Queensland, Australia, 4220
QLD Health - AIDS Medical Unit
Brisbane, Queensland, Australia, 4002
Australia, South Australia
Care and Prevention Programme
Adelaide, South Australia, Australia
Australia, Victoria
Alfred Hospital
Melbourne, Victoria, Australia, 3004
Melbourne Sexual Health Centre
Melbourne, Victoria, Australia, 3053
Prahran Market Clinic
Melbourne, Victoria, Australia, 3141
Australia, Western Australia
Fremantle Hospital
Fremantle, Western Australia, Australia, 6160
Royal Perth Hospital
Perth, Western Australia, Australia, 6000

Sponsors and Collaborators

The National Centre in HIV Epidemiology and Clinical Research

Abbott

Boehringer Ingelheim Pharmaceuticals

GlaxoSmithKline

Bristol-Myers Squibb

Merck

Hoffmann-La Roche

Virco

Diagnostic Technology

Perkin Elmer Biosystems

Investigators

Study Chair:

Sean Emery, PhD

The National Centre in HIV Epidemiology and Clinical Research at the University of New South Wales

More Information

National Centre in HIV Epidemiology and Clinical Research Homepage This link exits the ClinicalTrials.gov site

Study ID Numbers:	TVRP9901, ACTR012605000781640
Study First Received:	December 6, 2005
Last Updated:	June 8, 2006
ClinicalTrials.gov Identifier:	NCT00262717
Health Authority:	Australia: Department of Health and Ageing Therapeutic Goods Administration

Keywords provided by The National Centre in HIV Epidemiology and Clinical Research:

HIV drug resistance testing
Treatment Experienced

Study placed in the following topic categories:

Virus Diseases
Sexually Transmitted Diseases, Viral
HIV Infections
Sexually Transmitted Diseases

Acquired Immunodeficiency Syndrome
Retroviridae Infections
Immunologic Deficiency Syndromes

Additional relevant MeSH terms:

Communicable Diseases
RNA Virus Infections
Slow Virus Diseases

Immune System Diseases
Lentivirus Infections
Infection

ClinicalTrials.gov processed this record on January 16, 2009